The pharmaceutical industry is at a turning point: the wave of biologic drug patent expirations is creating an unprecedented landscape for biosimilars. This phenomenon, known as the “patent cliff,” is opening the door to unparalleled competition in the production of more accessible and sustainable treatments for healthcare systems worldwide.

According to the 10th edition of The Impact of Biosimilar Competition by IQVIA, biosimilars have gained significantly more traction than generics in the pharmaceutical market, as biologics still outpace small molecules by 3x. By 2030, 69 biologic medicines will lose exclusivity, creating a €28 billion market opportunity.

To better understand this context, we spoke with José Ramón Millán, Global Portfolio & Partnering Director at mAbxience, who explained that “biosimilars are in a golden era.” Beyond patent expirations, another key factor is at play: “The rate of adoption by healthcare authorities is accelerating,” Millán points out.

This regulatory momentum and growing expertise in biosimilar development have led to increased confidence in these treatments. European and Western countries, traditionally dominated by reference biologics, are now actively promoting biosimilars to reduce costs without compromising quality.

Riding the second wave of opportunity

Biosimilar development is not a new phenomenon. It began in the early 2000s when the European Medicines Agency (EMA) established the first regulatory framework for biosimilars. In 2006, Europe became the first region to approve a biosimilar, and since then, regulations have evolved to facilitate their broader adoption across markets.

While Europe saw a faster uptake of biosimilars, the United States followed a different path. Although the Biologics Price Competition and Innovation Act (BPCIA) created a regulatory pathway in 2010, the FDA did not approve its first biosimilar, filgrastim, until 2015—almost a decade after Europe. This initial delay was largely due to prolonged patent litigation and market strategies that hindered competition.

Another critical factor has been interchangeability regulations, which have historically been more restrictive in the U.S. than in Europe. Until recently, only a handful of biosimilars had received this designation, limiting their automatic substitution at pharmacies and slowing market penetration.

Today, we are in what experts call the “wave 2” of patent expirations. The first wave (2010–2020) saw the introduction of biosimilars for infliximab, trastuzumab, and rituximab, paving the way for biosimilars in oncology and autoimmune diseases. Now, this second wave includes the expiration of key monoclonal antibody patents, unlocking new opportunities for competition and cost optimization in healthcare.

We are witnessing a transformation in access to biotechnological treatments, with a direct impact on the sustainability of healthcare systems. The patent expiration wave is not just a challenge for the industry—it is also a unique opportunity to solidify biosimilars as an effective and accessible solution in global healthcare.

mAbxience: leaders in biosimilar manufacturing

In this evolving landscape, mAbxience plays a key role in biosimilar manufacturing. With over 14 years of experience, we have a portfolio of four commercialized biosimilars and six more in development, reinforcing our commitment to making high-quality biologic treatments more accessible and sustainable.

To learn more about our solutions, contact us here.